CN115770255A - 一种用于辅助治疗癌性发热的组合物 - Google Patents
一种用于辅助治疗癌性发热的组合物 Download PDFInfo
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- CN115770255A CN115770255A CN202111042089.4A CN202111042089A CN115770255A CN 115770255 A CN115770255 A CN 115770255A CN 202111042089 A CN202111042089 A CN 202111042089A CN 115770255 A CN115770255 A CN 115770255A
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Abstract
本发明涉及一种辅助治疗癌性发热的组合物，该组合物包含甜菜碱、B族维生素、葡萄糖酸锌、葡萄糖酸镁和辅料。该组合物具有用于有发热症状的恶性肿瘤患者退热的用途。
Description
技术领域
本发明涉及一种辅助治疗癌性发热的组合物，适用于治疗癌症患者的发热症状，本发明属于医药健康领域。
背景技术
癌性发热体温一般在37.5～38.5摄氏度之间，血常规中血象可以无异常，C反应蛋白、血沉等指标可以在正常范围，低热持续时间比较长，一般没有畏寒、寒战等症状。癌性发热多见于肿瘤晚期患者，由于肿瘤细胞增殖过快，出现缺血坏死而出现吸收热，另外恶性肿瘤细胞浸润激活白细胞释放致热原，肿瘤细胞自身也会释放出内源性致热原会引起发热；肿瘤侵犯脑部影响体温调节中枢会引起发热。恶性淋巴瘤患者发热比较常见，出现发热、盗汗、消瘦、瘙痒等全身症状时，称为B症状，有B症状的恶性淋巴瘤病人预后相对较差。
临床上针对癌症患者发热的治疗手段是在常规抗癌治疗的同时加上非甾体抗炎药物，但是这类药物胃肠道刺激大，不良反应较多，严重者可致胃溃疡、消化道出血等，特别是癌症患者对于药物的敏感性更明显，如出现严重不良反应无疑雪上加霜。所以，有效、温和、无副作用风险的退热治疗对于癌症患者来说是非常有益的，有利于病情的整体缓解。
本发明提供一种组合物，由甜菜碱、B族维生素、葡萄糖酸锌，葡萄糖酸镁组成，研究证实该组合物制成的食品或保健食品具有温和退热作用，并且没有胃肠道毒副作用的风险，特别适用于辅助治疗癌症患者的发热，有利于病情缓解，是一种更佳的产品。
发明内容
本发明的目的在于提供一种组合物，该组合物在制备成食品或保健品的形式用于癌症患者发热症状的辅助治疗。
为实现上述目的，本发明采用以下技术方案：
一种用于辅助治疗癌性发热的组合物，含有:(1)甜菜碱，(2)B族维生素，(3)葡萄糖酸锌，(4)葡萄糖酸镁，(5)辅料。
在本发明中，所述组合物，以重量份计，含有甜菜碱10～500mg、B族维生素0.01～10mg、葡萄糖酸锌0.5～30mg、葡萄糖酸镁10～1000mg，优选甜菜碱100～400mg、B族维生素0.1～5mg、葡萄糖酸锌10～30mg和葡萄糖酸镁500～1000mg。
在本发明中，所述B族维生素选自维生素B2 0.1～4mg、维生素B6 0.2～5mg、维生素B120.2～10mg、叶酸类物质0.01m～2mg中的一种或多种。
在本发明中，所述的叶酸类物质包括合成叶酸、5-甲基四氢叶酸、甲酰四氢叶酸、左亚叶酸钙或叶酸类物质的各种盐类，所述的维生素B6包括吡哆醛、吡哆醇、吡哆胺及其磷酸盐形式。
在本发明中，所述组合物可制备成普通片剂、咀嚼片剂、软胶囊剂、硬胶囊剂、粉剂及颗粒剂等口服剂型。
在本发明中，所述组合物具有制备可用于辅助治疗癌症患者发热症状的制品的用途。
本发明提供的组合物，对癌性发热患者有辅助治疗作用，且作用温和，无胃肠道不良反应等副作用风险，其特点在于，组合物中含有B族维生素、甜菜碱、葡萄糖酸锌和葡萄糖酸镁。
甜菜碱，又称三甲基甘氨酸，是天然存在于多数生物中的一种可食用的化合物，其中在甜菜、小麦、菠菜及甲壳类动物中含量最高。甜菜碱的基本生理功能包括作为渗透压调节剂及甲基供体(转甲基反应)。作为渗透压调节剂，甜菜碱可以保护细胞、蛋白质及酶不受外界极端环境的影响，如低水分环境，高盐及极端温度等。作为甲基供体，甜菜碱在肝脏及肾脏参与甲硫天然氨酸循环。天然甜菜碱已被证明可以保护内脏器官、降低心血管疾病危险因素并增强运动能力。因此，甜菜碱对多种人类疾病具有有益作用，例如肥胖症、糖尿病、癌症和阿尔茨海默病。
B族维生素是一类水溶性小分子化合物，该类化合物普遍以辅酶的形式广泛参与到各种生理过程中。其中，维生素B2进入人体后磷酸化，转变成磷酸核黄素及黄素腺嘌呤二核苷酸，与蛋白质结合成为一种调节氧化-还原过程的脱氢酶。脱氢酶是维持组织细胞呼吸的重要物质。缺乏它，体内的物质的代谢紊乱，出现口角炎、皮炎、舌炎、脂溢性皮炎、结膜炎和角膜炎等，补充维生素B2能够治疗上述炎症反应，同时也能治疗因炎症所引发的高热症状。
维生素B6是机体内许多重要酶系统的辅酶，参与氨基酸的脱羧作用、色氨酸的合成、含硫氨基酸的代谢和不饱和脂肪酸的代谢等生理过程，是动物正常发育、细菌和酵母繁殖所必需的营养成分。缺乏维生素B6容易引起：贫血症、脂溢性皮肤炎、舌炎。补充维生素B6同时能够治疗因炎症所引发的机体发热的症状。
维生素B12和叶酸是B族维生素复合体，是正常红细胞形成、组织和细胞修复和DNA合成的必需元素。B12和/或叶酸缺乏反映了其中一种或两者的慢性不足。长期叶酸或B12的缺乏可导致大细胞性贫血，其特点是红细胞生成减少，体积变大，携氧能力降低。由于贫血，病人会感到乏力、头晕、气促。B12缺乏也会导致不同程度的神经损害，引发手和脚的刺痛麻木及从混淆、易怒到严重痴呆的心智改变。
叶酸是水溶性B族维生素，参与机体的细胞分裂、繁殖和代谢等重要反应，以及核酸、氨基酸的合成，因此，膳食中叶酸缺乏或叶酸摄取不足均会引起机体发生多系统受损。叶酸代谢障碍可能与叶酸缺乏有相同的生物学后果。维生素B作为辅酶参与了嘌呤和嘧啶的合成，它们的不平衡可能影响核酸代谢，并且造成DNA的合成与修复障碍，进而参与了致癌的过程。提高组织叶酸浓度可保护组织、预防肿瘤的发生。
葡萄糖酸锌在体内解离为锌离子和葡萄糖酸，参与核糖核酸和脱氧核糖核酸的合成，为体内许多酶的重要组成成分，可促进体内含锌酶功能和创口愈合,对生长发育尤为重要，缺乏时生长停滞、生殖无能、伤口不易愈合、机体衰弱，还可发生结膜炎、口腔炎、舌炎、食欲缺乏、慢性腹泻、味觉丧失及神经症状等。用于治疗因缺锌引起的生长发育迟缓、营养不良、厌食症、复发性口腔溃疡、痤疮等。
葡萄糖酸镁口服具有明显的肌肉松驰作用，可缓解冠状动脉痉挛，减少乙酰胆碱的释放，维持体内电解质的平衡。可抑制Cr、Al元素的毒性、加速体内致癌物质硝酸盐和亚硝酸盐的代谢。能激活腺苷酸环化酶，阻止过敏物质的释放，防止哮喘发作。能抑制血管动脉的神经和迷走神经，使冠脉扩张，具有钙拮抗和膜稳定等作用。葡萄糖酸镁在体内均由葡萄糖。
本发明提供一种由甜菜碱、B族维生素、葡萄糖酸锌和葡萄糖酸镁组成的组合物，该组合物对癌症患者的发热具有辅助治疗作用，且至今为止没有相关文献报道。发明人将所述组合物制备的营养保健品应用于癌症患者的营养补充中，发现其具有退烧的意想不到功效，且通过动物实验进一步验证了这一功效。
具体实施方式
此处所描述的具体实施例仅仅用以解释本发明，并不用于限定本发明。
实施例1：由本发明组合物对肺癌患者的退烧作用的临床病例分析
患者信息：张某，女，52岁，该患者在湖南省某医院诊断为肺恶性肿瘤(右肺，腺癌)，血液体检报告结果如下所示：
| 编号 | 检测项目 | 结果 | 参考值范围 |
| WBC | 白细胞数目 | 15.78↑ | 4-10*10^9/1 |
| Neu％ | 中性粒细胞百分比 | 86.84↑ | 45-77％ |
| Neu<sup>#</sup> | 中性粒细胞数目 | 13.71↑ | 2-7.7*10^9/1 |
| Lymph％ | 淋巴细胞百分比 | 7.62↓ | 20-40％ |
| Lymph<sup>#</sup> | 牛淋巴细胞数目 | 1.2 | 0.8-4*10^9/1 |
| MON％ | 单核细胞百分比 | 4.5 | 3-8％ |
| MON<sup>#</sup> | 单核细胞数目 | 0.71 | 0.12-0.8*109/1 |
| Eos％ | 嗜酸性粒细胞百分比 | 1.04 | 0.5-5％ |
| Eos<sup>#</sup> | 嗜酸性粒细胞数目 | 0.15 | 0.05-0.5*10^9/1 |
| Bas％ | 嗜碱性粒细胞百分比 | 0.1 | 0-1％ |
| Bas<sup>#</sup> | 嗜碱性粒细胞数目 | 0.01 | 0-0.1*10^9/1 |
| HCT | 红细胞压积 | 21.62↓ | 36-50％ |
| RBC | 红细胞数目 | 2.41↓ | 3.5-5.5*10^12/1 |
| MCV | 平均红细胞体积 | 89.6 | 86-100fL |
| HGB | 血红蛋白浓度 | 66.2↓ | 110-160g/L |
| MCH | 平均血红蛋白含量 | 27.4 | 26-31pg |
| MCHC | 平均血红蛋白浓度 | 306.2↓ | 310-370g/L |
| RDW-SD | 红细胞分布宽度SD | 58.21↑ | 37-50％ |
| RDW-CV | 红细胞分布宽度CV | 19.01 | ％ |
| MPV | 平均血小板体积 | 13.44↑ | 9-13fL |
| PDW | 血小板分布宽度 | 21.64↑ | 9-17fL |
| PLT | 血小板数目 | 177.4 | 100300*10^9/1 |
| PCT | 血小板压积 | 0.24 | ％ |
| P-LCR | 血小板大细胞百分比 | 49.54↑ | 13-43％ |
该患者住院期间持续低热超过一个月，医生在给以该名患者相应的肺癌药物治疗基础上，应用本发明提供的组合物配方制成的保健食品进行营养补充。
该保健食品具体由以下配方组成：
| 序号 | 成分 | 配方量 |
| 1 | 维生素B<sub>2</sub> | 0.2000g |
| 2 | 维生素B<sub>6</sub> | 0.2500g |
| 3 | 6S-5-甲基四氢叶酸钙 | 0.0950g |
| 4 | 维生素B<sub>12</sub>粉 | 0.2500g |
| 5 | 葡萄糖酸锌 | 1.1150g |
| 6 | 葡萄糖酸镁 | 32.4045g |
| 7 | 甜菜碱 | 20.00g |
| 8 | 柠檬酸 | 5.00g |
| 9 | 二氧化硅 | 10.00g |
| 10 | 麦芽糊精 | 170.00g |
| 11 | 菊粉 | 150.00g |
| 12 | 低聚果糖 | 120.00g |
| 13 | 赤藓糖醇 | 125.00g |
| 14 | 麦芽糖醇 | 116.50g |
| 15 | 葡萄果粉 | 250.00g |
| 制成 | 1000g，20g/袋 |
在合并服用该保健食品后，发现该癌症患者低热减退，对其体温变化监测如下所示：
表1：患者体温变化情况
从以上的癌症患者的体温变化结果可以看出，服用该保健品后8h体温下降，24h后基本达到正常体温范围，48h后体温稳定正常。本发明提供的组合物对于持续低热的癌症患者产生了降温的意想不到效果。经过保健品补充的患者精神状态亦有明显好转。
实施例2：由本发明组合物对结肠癌患者的退烧作用的临床病例分析
患者信息：刘某，男，73岁，该患者同为湖南省某肿瘤医院就诊患者，诊断为结肠癌。
该患者住院期间持续低热超过两周，医生在给以该名患者相应的结肠癌药物治疗基础上，应用本发明提供的如下配方的保健食品进行营养补充。
该保健食品具体由以下配方组成：
| 序号 | 品名 | 配方量 |
| 1 | 维生素B2 | 0.0160g |
| 2 | 维生素B6 | 0.0195g |
| 3 | 叶酸 | 0.0042g |
| 4 | 维生素B12粉 | 0.0450g |
| 5 | 葡萄糖酸锌 | 0.650g |
| 6 | 葡萄糖酸镁 | 25.20g |
| 7 | 甜菜碱 | 10.00g |
| 8 | 麦芽糊精 | 364.07g |
| 9 | 低聚果糖 | 100.00g |
| 10 | 木糖醇 | 320.00g |
| 11 | 菊粉 | 110.00g |
| 12 | 百香果粉 | 70.00g |
| 制成 | 1000g，20g/袋 |
在合并服用该保健食品后，同样发现该癌症患者低热减退，对其体温变化监测如下所示：
表2：患者体温变化情况
从以上的癌症患者的体温变化结果可以看出，服用该保健品后8h体温下降，24h后基本达到正常体温范围，48h后体温稳定正常。本发明提供的组合物对于持续低热的结肠癌症患者亦产生了明显的降温的效果，经过保健品补充的患者精神状态亦明显好转。说明本发明提供的含有营养素、甜菜碱及矿物质配伍的保健食品对癌性低热有辅助退热的效果。
Claims (7)
1.一种用于辅助治疗癌性发热的组合物，含有:(1)甜菜碱，(2)B族维生素，(3)葡萄糖酸锌，(4)葡萄糖酸镁，(5)辅料。
2.根据权利要求1所述组合物，其特征在于，以重量份计，含有甜菜碱10～500mg、B族维生素0.01～10mg、葡萄糖酸锌0.5～30mg、葡萄糖酸镁10～1000mg。
3.根据权利要求2所述组合物，其特征在于，以重量份计，含有甜菜碱100～400mg、B族维生素0.1～5mg、葡萄糖酸锌10～30mg、葡萄糖酸镁500～1000mg。
4.根据权利要求1所述组合物，其特征在于，所述B族维生素选自维生素B2 0.1～4mg、维生素B6 0.5～5mg、维生素B120.2～10mg、叶酸类物质0.01～2mg中的一种或多种。
5.根据权利要求4所述组合物，其特征在于，所述的叶酸类物质包括合成叶酸、5-甲基四氢叶酸、甲酰四氢叶酸、左亚叶酸钙或叶酸类物质的各种盐类，所述的维生素B6包括吡哆醛、吡哆醇、吡哆胺及其磷酸盐形式。
6.根据权利要求1所述的组合物，其特征在于，所述组合物可制备成普通片剂、咀嚼片剂、软胶囊剂、硬胶囊剂、粉剂及颗粒剂等口服剂型。
7.权利要求1所述的组合物用于辅助治疗癌症患者发热症状的用途。
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